VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer (VinCaT)
Primary Purpose
Metastatic Breast Cancer
Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
vinorelbine
carboplatin
trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring advanced, her-2 positive
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of breast cancer
- Stage IV disease
- None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
- Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
- ECOG Performance Status 0-2
- Age >18 and < 75 years
- Left Ventricular Ejection Fraction (LVEF) >50%
- Life expectancy >3 months
- Signed informed consent
Exclusion Criteria:
- Absence of measurable or evaluable disease
- Life expectancy < 3 months
- ECOG performance status > 2
- History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
- Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
- Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
- Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
- Creatinine > 1.5 x the upper normal limits
- GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
- GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
- Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
- Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- Male gender
- Pregnant or lactating women
- Refusal or incapacity to provide informed consent
- Inability to comply with follow up
Sites / Locations
- Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vinorelbine, carboplatin, trastuzumab
Arm Description
Outcomes
Primary Outcome Measures
objective response rate
side effects
Secondary Outcome Measures
time to progression
overall survival
Full Information
NCT ID
NCT00431704
First Posted
February 5, 2007
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
1. Study Identification
Unique Protocol Identification Number
NCT00431704
Brief Title
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
Acronym
VinCaT
Official Title
Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.
Detailed Description
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
advanced, her-2 positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vinorelbine, carboplatin, trastuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Description
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
after 3 and 6 cycles of therapy
Title
side effects
Time Frame
after every cycle of therapy
Secondary Outcome Measure Information:
Title
time to progression
Time Frame
at 12 months, end of study
Title
overall survival
Time Frame
at 12 months, end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological diagnosis of breast cancer
Stage IV disease
None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
ECOG Performance Status 0-2
Age >18 and < 75 years
Left Ventricular Ejection Fraction (LVEF) >50%
Life expectancy >3 months
Signed informed consent
Exclusion Criteria:
Absence of measurable or evaluable disease
Life expectancy < 3 months
ECOG performance status > 2
History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
Creatinine > 1.5 x the upper normal limits
GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
Male gender
Pregnant or lactating women
Refusal or incapacity to provide informed consent
Inability to comply with follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea De Matteis, M.D.
Organizational Affiliation
NCI Naples, Division of Medical Oncology C
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D.
Organizational Affiliation
NCI Naples, Clinical Trials Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
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